This invention relates to palatable solid pharmaceutical compositions useful in humans and other animals. In particular, it relates to highly efficacious compositions comprising a pharmaceutical active in a lipid-containing matrix. Preferred compositions further relate to highly palatable tablets, which are chewable or liquify in the mouth, useful for the treatment of gastrointestinal disorders.
Pharmaceutical compositions may be produced in a variety of dosage forms, depending upon the desired route of administration of the active material. Oral dosage forms, for example, include such solid compositions as tablets, capsules, granules and bulk powders, and such liquid compositions as solutions, emulsions, and suspensions. The particular dosage form utilized may, of course, depend upon such factors as the solubility and chemical reactivity of the pharmaceutical active. Further, the dosage form may be selected so as to optimize delivery of the pharmaceutical active and/or consumer acceptability of the composition.
Tablet compositions offer many advantages, including ease of product handling, chemical and physical stability, portability (in particular, allowing ready availability to the consumer when needed), aesthetic acceptability, and dosage precision, (i.e., ensuring consistent and accurate doses of the pharmaceutical active). However, liquid formulations may offer advantages in the treatment of certain disorders, such as disorders of the upper gastrointestinal tract, wherein delivery of an active material dissolved or dispersed in a liquid ensures rapid and complete delivery to the afflicted area. In an effort to obtain the therapeutic advantages associated with liquid formulations as well as the broad advantages associated with solids, many chewable tablet formulations have been developed and described in the pharmaceutical literature. See, for example, L. Lachman, et al., The Theory and Practice of Industrial Pharmacy (2nd Ed., 1976).
Many such compositions are antacids, for the treatment of gastric hyperacidity and related disorders. Many antacid compositions in liquid form are quite effective due to the ready availability of the antacid active material (which is typically water-insoluble) suspended in a liquid vehicle. There are also many solid antacid formulations, typically chewable tablets, which are designed to deliver small particles of antacid active to the stomach after chewing of the tablet.
Chewable tablets, such as antacid tablets, often contain high levels of mannitol or similar binders as well as methylcellulose, glycine, or other binding agents. Other chewable tablets are described in the literature containing fatty materials. See, for example, U.S. Pat. No. 4,230,693, Izzo, et al., issued Oct. 28, 1980, U.S. Pat. No. 4,327,076, Puglia, et al., issued Apr. 27, 1982, U.S. Pat. No. 4,327,077, Puglia, et al., issued Apr. 27, 1982, U.S. Pat. No. 4,533,543, Morris, et al., issued Aug. 6, 1985, and U.S. Pat. No. 4,581,381, Morris, et al., issued Apr. 8, 1986.
Many such solid antacid formulations fail to offer equivalent efficacy to liquid antacid compositions, for a variety of reasons. For example, the tablets may be incompletely chewed due to poor palatability of the composition. This problem is particularly acute with antacids, since the active materials in these products often have a metallic flavor and an astringent, chalky mouth feel. Such compositions may also have a gummy texture, and are subject to "taste fatigue", i.e., the composition is perceived to be less palatable after ingestion of multiple doses. Further, the binders and other materials used in such chewable tablets may prevent rapid and effective delivery of active materials to the stomach.
It has been found that tablet formulations containing selected lipid materials, emulsifiers and particulate materials are highly palatable and effective compositions for the delivery of pharmaceutical active materials. Such compositions afford better taste, mouth feel, and storage stability than compositions known in the art. For example, such compositions containing selected materials with selected particle sizes, and formulated to have a selected product viscosity, afford improved palatability when compared to other lipid containing compositions.